Frequently Asked Questions About In Our DNA SC

In Our DNA SC is a large-scale community research project investigating how DNA impacts health, with a broader goal of learning how to offer more personalized health care to our patients and community.

DNA contains the genetic information that provides the instructions that led to you, including your physical traits (like eye color) and insights into your ancestral roots, but also provides health information. There are many similarities in everyone's DNA, but there are important differences, and your DNA code is unique to you. We are still learning how DNA impacts health, and the insights we learn from studies like In Our DNA SC will help us provide more personalized health care for our patients and community.

In Our DNA SC is run by the Medical University of South Carolina (MUSC) in collaboration with Helix, a population genomics company that works with major health systems across the US to launch programs similar to In Our DNA SC.

We currently welcome anyone 18 years and older with no history of bone marrow and/or stem cell transplants to join In Our DNA SC. Participants must also be able to read and write in English or Spanish in order to enroll.

By contributing your genetic and health history information to In Our DNA SC, researchers will be able to learn more about how DNA impacts health and disease. The more we understand, the more we can improve health care for you, your family and your community for generations to come. There is also a chance that the information you learn from In Our DNA SC could impact your health care now.

No. Participation is free and the genetic testing provided will not be billed to your health insurance or to you. If your sample collection occurs during a clinic visit, your participation will not affect normal charges for that visit.

If you test positive for one of the conditions being screened, you will be offered a genetic counseling appointment at no cost. However, any follow-up beyond initial genetic counseling will be considered clinical care and you or your insurance company will be responsible for payment.

Signing up is simple and something you can do from home.

If you already have an established MUSC MyChart Account, click on the “Sign Up Now” button above. You will be asked to log in with your MUSC MyChart credentials which will then send you directly to the consent form. If you do not have an established MUSC MyChart Account, please reference the “Sign up and View Results” webpage for detailed instructions.

Once you are able to log into MyChart and access the consent form please read over the consent form carefully. You will be asked to answer questions regarding the consent form and study before being able to provide your signature electronically at the bottom of the document. You can draw your electronic signature using your computer mouse, stylus, or finger if using a mobile device. Be sure to authorize your signature by clicking the checkbox below the electronic signature box. Once you have reviewed the consent form, you can download a copy for your records and then choose your preferred sample collection method.

You may also review the study website in Spanish, En Nuestro ADN SC. Those who click the consent link from the Spanish version of the website will be re-directed to a Spanish version of the consent form for review, with the option of toggling back to the English version of the consent form.

No. Research studies include only people who choose to participate. It is your choice whether or not you want to take part in this study and your decision will not impact your care at MUSC.

If you have questions about the study, you can contact the In Our DNA SC research team at InOurDNASC@musc.edu or by calling 843-876-0582.

If you have questions about your Helix account, you can contact support@helix.com or by calling toll-free at 844-211-2070.

In Our DNA SC is registered on www.clinicaltrials.gov, a publicly available registry of clinical trials and research studies, under the Helix Research Network program name. This website will provide general information about the research program and where it is open to enrollment throughout the country. This website will not include information that can identify you or any participants. At the end of the study, the website will include a summary of the results. You can review the listing of this research program on this website at any time.

Once you have reviewed and signed the consent form, you are now considered an enrolled participant in the study and will need to provide a sample. You will receive a "Next Steps"message that includes details on how to provide your sample.

If providing a buccal (cheek swab) sample, it is important not to eat, drink, smoke, or chew gum for 30 minutes before you provide your sample. If providing a blood sample, you are not required to be in a fasted state (meaning you are able to eat and drink as usual). In addition, a sample should not be collected within 30 days of a blood transfusion or blood products. 

Yes, if you would like to change the type of sample collection you initially selected (i.e., at home or in-person), please contact the In Our DNA SC study team by emailing inourdnasc@musc.edu or calling 843-876-0582.

Once your sample is collected and received by Helix, the analysis on your DNA, known as sequencing, will begin. Sequencing reads the code contained within the DNA so that it can be used for research. You will also receive an email from Helix offering you the opportunity to create an optional Helix account.

Yes. You will receive health results that will indicate if you have inherited certain risk factors in your DNA, meaning that the risk has been passed from generation to generation in your family. Your family history alone, or standard medical screening tests, do not always identify risks for these conditions. Specifically, the test will tell you about your genetic risk for the following three conditions that the US Centers for Disease Control and Prevention (CDC) and other medical professionals consider to be important enough to warrant further investigation of treatment:

• Familial hypercholesterolemia (FH): A hereditary form of very high cholesterol that causes heart disease at an earlier age than the general population. In Our DNA SC exclusively reports on the following genes related to FH: LDLR, LPLRAP1, APOB, and PCSK9.
• Hereditary breast and ovarian cancer (HBOC): A hereditary form of breast and ovarian cancer. In Our DNA SC exclusively reports on the following genes related to HBOC: BRCA1 and BRCA2.
• Lynch syndrome (LS): The most common cause of hereditary colorectal (colon) cancer - people with Lynch syndrome are more likely to get colorectal cancer and at a younger age. In Our DNA SC exclusively reports on the following genes related to LS: MLH1, MSH2, MSH6, PMS2, and EPCAM.

In addition, if you sign up for a Helix account, you'll receive information about your genetic ancestry and how your DNA may influence certain traits, such as your caffeine metabolism.

About 1 to 2% (1 to 2 people out of 100) will be found to have a risk for one of the inherited cancer or heart conditions that are part of this study. These participants will have an opportunity to speak with a genetic counselor, who will explain how to interpret the results and recommended follow-up clinical care. Additional results with clinical importance may also be available for you in the future.

If you have a personal or family history of a condition covered by this test, you may want to speak with a genetic counselor or your personal doctor about whether additional or different genetic testing may be appropriate for you. A genetic counselor is a medical professional specifically trained to help you understand how your genetic information may impact your health, as well as your family's. Those communications would be separate from In Our DNA SC.

Please note, just because you or a family member has tested positive for a predisposition to a condition in the past, does not mean you will get it in the future.

Once you have signed the informed consent and provided your sample, you will be able to view your results as they become available. Your genetic ancestry and traits results are typically ready within 2 to 4 weeks of your sample being received by Helix. It can take an additional 2 weeks before your health results are ready to view, as extra steps are taken to ensure your health results are accurate.

Helix will email you as your results become available to view in the Helix online portal if you created a Helix account. To view your results in the Helix online portal, please follow these steps:

1. Visit Helix.com
2. Click “Participant Login” at the top of the screen
3. Select “Continue with your Online Health Account”
4. Select “Medical University of South Carolina” as your Health System
5. Log in with your MyChart information
6. You will be able to view your results by clicking on the arrows beside “Ancestry,” “Traits,” and “Health” when they become available

Once your health results are available, they will be returned to your medical record and will be available in MyChart, under the “Test Results” tab and listed as “Helix Molecular Screen.” You will receive a MUSC Health MyChart message notification when the results are available.

Creating a Helix account will give you access to additional information and features that are not available in your MUSC Health MyChart account, such as:

• Dashboard view of the status of your results – from when your sample is received in the lab to when your results are ready.
• Learning about your Ancestry and Traits information.
• Ability to easily download a PDF version of your Helix Health results report when available.

Yes, your health results will be saved in your medical record and your healthcare provider will have access to them to inform your future care plans.

Over time, more health-related results may be returned to you as researchers and health care providers learn more about how DNA impacts human health. You may be contacted in the future if more information or samples are needed. However, you do not have to agree to provide more information or additional samples if you do not want to.

The In Our DNA SC study team is aware of a recent influx of fraud schemes involving genetic testing. Scammers may offer genetic testing, request insurance information for identity theft, or impose fraudulent billing. Fraudsters appear to be targeting beneficiaries through telemarketing calls.

The In Our DNA SC study team will never call you to request insurance information, or to request payment. Participants will never be directed to a 3rd party testing agency for additional testing that requires payment.

Please reach out to the In Our DNA SC study team by email or calling 843-876-0582 with any questions or concerns.

Federal law generally prohibits health insurance companies from using your genetic information against you. 

Under the Genetic Information Nondiscrimination Act of 2008 ("GINA"), it is illegal for health insurance companies and group health plans to discriminate against you based on your genetic information–including genetic information generated or obtained from your participation in the In Our DNA SC study. GINA prohibits health insurers from requiring you to provide them with your genetic information or the genetic information of your family members as a condition of coverage, or from using such genetic information to make eligibility, coverage, underwriting, or pricing decisions. In other words, GINA prohibits health insurers from requesting your genetic information, refusing coverage based on your genetic information, or from charging you more based on your genetic information.

In addition, the Affordable Care Act of 2010 ("ACA") prohibits health insurance companies from refusing to cover you or from charging you more simply because you have a "pre-existing condition."  To the extent your participation in the study leads to the eventual diagnosis of any particular condition (as opposed to simply a genetic predisposition to such a condition), the ACA prohibits eligibility and pricing discrimination based on that diagnosis.

Please note that the protections afforded by GINA and the ACA do not extend to other forms of insurance, including life insurance, long-term care insurance, or disability insurance.  In addition, GINA's protections do not apply to active members of the U.S. military, individuals insured through Federal Employees Health Benefits Plans, and individuals receiving health-related services through the Veterans Administration or Indian Health Service.  However, individuals in each of these groups are similarly protected under several other laws and regulations.

The information you contribute to In Our DNA SC will be used by researchers to study a wide range of questions around how DNA can impact health. All research will have to be approved by institutional ethics boards before researchers can access the information, and all information used for research purposes will be de-identified. This means that researchers will not see any information that could be used to identify you. We will share discoveries that are made by In Our DNA SC researchers through our website and newsletters.

Your privacy is very important to us, and we take many steps to ensure it is protected, such as:

• Your information (your genetic information and health records) will be stored in secure databases.
• We limit and closely monitor who can access your data.
• We limit who is allowed to see information that could identify you, like your name or contact information.
• Researchers who have access to your data must be trained and certified to work with this type of research data.
• You can choose to withdraw and stop sharing your information at any time.

With few exceptions, GINA prohibits employers from discriminating against their employees on the basis of genetic information in any aspect of employment, including hiring, firing, pay, job assignments, promotions, layoffs, training, fringe benefits, or any other term or condition of employment. The law similarly prohibits labor organizations from excluding, expelling, or otherwise discriminating against an individual based on genetic information.

Importantly, GINA's employment protections do not extend to all employees or in all circumstances. Most notably, these protections do not apply to employees at companies with fewer than 15 employees or to active members of the U.S. military.

Currently, federal and South Carolina state law protections against discrimination based on genetic information by health insurers do not extend to providers of life, disability, and long-term care insurance. That means companies offering these kinds of insurance may request access to genetic information in your medical record as part of the insurance application process (including information generated as part of your participation in this study) and may legally consider this information in deciding whether to extend you coverage or in determining the price they charge you.

If you already have an existing life insurance, disability insurance, or long-term care insurance policy, new information about your health (including genetic information) generally may not be used to deny you continuing coverage under those policies. However, the terms of individual policies vary significantly and you should read your policy carefully to understand how results could impact your coverage or insurance rates.

If you decide to participate in the In Our DNA SC study, your information will be stored in databases that are maintained and monitored by a team of IT and security professionals who are committed to safeguarding the information stored in those systems. These systems include numerous technical, physical and administrative safeguards that meet, and in some cases exceed, industry best privacy and cybersecurity practices, including standards established by the National Institutes of Science and Technology ("NIST"), the Association of International Certified Professional Accountants ("AICPA"), and applicable state and federal laws, such as HIPAA. Some of the technical safeguards we've implemented include rigorous identification, authorization and access controls, audit and logging procedures, configuration management, system and communication protections and endpoint monitoring, data loss prevention systems, encryption of data at rest and in transit, and vendor risk management procedures. Although we generally do not share the details of how these controls and safeguards have been configured, we can share that our privacy and security programs are reviewed annually by third party auditors to ensure our safeguards are operating as expected and, in a manner, consistent with industry standards.

We want to make sure you understand what is involved in the study so you can make an informed decision about whether or not to participate. If you decide to participate, we ask you to review and sign the In Our DNA SC informed consent form. You can review a copy of the consent document here (PDF).

You may withdraw from the study at any time by reaching out to the In Our DNA SC research team by emailing InOurDNASC@musc.edu, or calling 843-876-0582. Your decision to withdraw will not affect the medical care you receive. After you withdraw, your DNA and health information will no longer be analyzed or included in this research project. However, any results that are already in your healthcare records cannot be removed.